Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- intracranial progression free survival (IPFS) rate
研究概览
简要总结
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
详细描述
A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
- •the number of BMs ≤ 3
- •the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
- •Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
- •Age: 18-75 years old;
- •Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.
排除标准
- •patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
- •unable or unwilling to comply with the study protocol;
- •patient whose survival expectancy was less than 3 months;
- •the large BM locates in brainstem;
- •patient who anticipated in other clinical trials of brain metastases;
- •the large lesions have been treated with SRT in other hospitals;
- •pregnant patients or female patients whose HCG is positive.
研究组 & 干预措施
CRT group
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
干预措施: Temozolomide (Drug)
CRT group
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
干预措施: hypofractionated radiotherapy (Radiation)
RT group
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
干预措施: hypofractionated radiotherapy (Radiation)
结局指标
主要结局
intracranial progression free survival (IPFS) rate
时间窗: up to 2 years
IPFS was defined as the interval from the beginning of radiation to any intracranial progression
次要结局
- local control rate(up to 2 years)
- Brain metastasis-specific survival (BMSS) rate(up to 2 years)
- overall survival (OS) rate(up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria(acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT)
研究者
Jianping Xiao
Principal Investigator
Chinese Academy of Medical Sciences